FLYNN III-CHILD BAG-MASK UNIT ETC— 510(k) K834400

Substantially Equivalent

O-Two Systems Intl., Inc.

FDA 510(k) clearance K834400 for FLYNN III-CHILD BAG-MASK UNIT ETC, Substantially Equivalent on 1984-01-13. Applicant: O-Two Systems Intl., Inc..

Clearance details

Applicant: O-Two Systems Intl., Inc.
Product code: Code BTM
Advisory panel: Anesthesiology
Date received: 1983-12-14
Decision date: 1984-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.